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Trial registered on ANZCTR


Registration number
ACTRN12613001127796
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
9/10/2013
Date last updated
4/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot evaluation of the Lifestlye-Integrated Functional Exercise Program as a falls prevention intervention for older people with vision impairment.
Scientific title
Older people with vision impairment using the Lifestyle-Integrated Functional Exercise Program (LiFE) to reduce falls risk in a single arm pilot study to evaluate feasibility and acceptability of this program
Secondary ID [1] 283351 0
NIL
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older people with vision impairment and their physical performance 290248 0
fear of falling 290249 0
Condition category
Condition code
Musculoskeletal 290639 290639 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LiFE program is a structured approach to improving the balance and strength of people at high risk of falls. The program is designed in such a way that participants incorporate the 8 balance and 7 strength activities into their daily lives and routines to gradually form habits (Clemson, Munro, Fiatarone Singh 2013). Lally and Gardner (2011) argue that habit formation is largely dependent on repetitive behavior being conducted in a consistent environment. Participants of the LiFE program are taught these activities within their own home thus maintaining the consistency of the environment (Clemson et al 2012; Lally and Gardner 2011). Additionally daily routines provide the ‘cue’ that participants need to promote the performance of the activity (Lally and Gardner 2011).
The balance activities are the tandem stand, tandem walking, one-leg stand, leaning from side-to-side, leaning forwards and backwards, stepping over objects, stepping over objects sideways and stepping in different directions. The strength activities aim to increase the load on the legs and include; bending knees, sit to stand, standing on toes and heels, walking up stairs, walking sideways and tightening muscles (Clemson, Munro, Fiatarone Singh 2013). These activities will be taught by Orientation and Mobility Instructors employed by Guide Dogs NSW/ACT. These instructors are familiar in working with the vision impaired population and will thus appropriately tailor these activities to the needs of the participants. The LIFE program will be conducted over 5 home visits (with one each week) as well as 2 booster visits and 2 phone calls (one each fortnight as the participant becomes more familiar with the program) over the course of 3 months. It is expected that each of the 5 home visits will be conducted over an hour, whereas the booster visits and phone calls should not take longer than half an hour.
Overall the duration of the program is 3 months. However there will also be a follow up assessment at the end of the 3 month period and at 12 months from the baseline assessment, to measure any improvements to the participants’ balance and strength abilities. Thus the total duration of the study is 12 months.
Intervention code [1] 288075 0
Behaviour
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290653 0
Semi-structured interviews will be conducted pre and post the intervention. In the pre-intervention interviews a range of questions will be asked to gain behavioural, normative and control beliefs in regards to the participant’s view of undertaking the LiFE program. These questions have been adapted from Yardley et al which utilises the Theory of Planned Behaviour to analyse the participants’ views.
Questions to elicit behavioural beliefs
*Do you have any ideas about doing the LiFE program? Have you previously done anything similar? How do you feel about doing this program?

Questions to elicit normative beliefs
*What do you know about the LiFE program from what you have been told? Does this affect how you feel about doing the LiFE program? How do your friends and family feel about the LiFE program? Do their opinions of the LiFE program affect your views on it?

Questions to elicit control beliefs
*How easy do you think it will be to fit the LiFE program into your daily life? Can you think of any problems with do the LiFE program? What things do you think might help you do the LiFE program?

The Post-intervention questions have been adapted from the Attitude to Falls-Related Intervention Scale (AFRIS) which allow the participants to evaluate their experience in undertaking the LiFE program.
*How do you think the LiFE program was good for you?
*How do you feel your balance and strength has changed?
*Were there any unexpected outcomes from doing the LiFE program?
*What is the main thing you learned from the lessons?
*How has this impacted on your everyday activities?
*Describe how you found doing the LiFE program? easy/hard?, enjoyable?
*Do you find that your mobility has changed since completing the LiFE program?
*How do you feel about continuing to do the LiFE program? Are there any things preventing you?
*Would you recommend the LiFE to others like yourself?


Yardley, L, Dennison, L., Coker, R., Webley, F., Middleton, K., Barnett, J., Beattie, A., Evans, M., Smith, P., Little, P. 2010, ‘Patients’ views of receiving lessons in the Alexander Technique and an exercise prescription for managing back pain in the ATEAM trial’, Family Practice, vol. 27, pp. 198-204.
Timepoint [1] 290653 0
The pre intervention interviews will be conducted prior to the first home visit and the post intervention interviews will be conducted at the 3 month stage after the implementation of the program.
Primary outcome [2] 290654 0
The purpose of Short Physical Performance Battery is used as a measure of the participant's balance and strength capabilities. It has three main components to be measured. The first involves measuring the participant’s standing balance in 4 stances, depending on their level of ability. These stances range from; feet together, feet apart (with and without physical assistance), semi-tandem, tandem, and single leg. The participant is required to hold their feet in each position for 10 seconds. They are allowed to use their arms, bend their knees or move their body in order to maintain their balance.

The second component requires the participant to go from sitting (on a chair with a height of 45cm) to a standing position 5 times without using their arms. The participant is required to complete this assessment in the shortest amount of time and it will be recorded by the instructor. Note: if the participant is also allowed physical assistance or to use their hands if they are otherwise unable and this will be noted on the recording form.

The final component is a timed 4 metre walk. The participant is required to walk as quickly and as safely as they can for 4 metres. The time and the number of steps will be recorded. The participant is also able to use physical assistance or walking aids if necessary.

For all of these measures, the instructor will be within reach of the participant to guide the participant and if their assistance is necessary.
Timepoint [2] 290654 0
The outcome assessments will be conducted at 3 points over the course of the pilot study; at baseline, at the 3 month interval and at 12 months from the baseline assessment.
Primary outcome [3] 290655 0
The Late Life Function and Disability Instrument (LLFDI) is used to assess the limitations people face in performing daily tasks and engaging in the community, which ultimately aims to provide an indication of one’s mobility (Sayers et al 2004). The first questionnaire in the LLFDI is used to measure the difficulty people face when performing the 32 stated tasks which range from unscrewing a lid to walking up a flight of stairs, thus measuring the participant’s function. This component measures upper extremity, lower extremity and advanced lower extremity abilities (LaPier 2012). The second questionnaire of the LLFDI is divided into two parts and measure a person’s disability by measuring the participant’s capability and frequency of performing the 16 tasks. These tasks range from ability to prepare meals to their involvement in social activities.
The Short Falls Efficacy Scale is a measure of how concerned the participants are about the possibility of falling when undertaking 7 different activities. These activities include; getting dressed/undressed, taking a bath or shower, getting in or out of a chair, going up or down stairs, reaching for something above their head, walking up or down a slope and going to a social event.

LaPier, T. 2012, ‘Utility of the Late Life Function and Disability Instrument as an Outcome Measure in Patients Participating in Outpatient Cardiac Rehabilitation: A Preliminary Study’, Physiotherapy Canada, vol. 64, no. 1, pp. 53-62.
Sayers, S., Jette, A., Haley, S., Heeren, T., Guralnik,J., Fielding, R. 2004, ‘Validation of the Late-Life Function and Disability Instrument’, Journal of the American Geriatrics Society, vol. 52, no. 9, pp. 1554-1559.
Timepoint [3] 290655 0
These assessments will be conducted at 3 points over the course of the pilot study; at baseline, at the 3 month interval and at 12 months from the baseline assessment.
Secondary outcome [1] 304983 0
NIL
Timepoint [1] 304983 0
NIL

Eligibility
Key inclusion criteria
To be eligible to participate it is necessary that potential participants have a vision impairment such that they require the services of the low vision clinic of Guide Dogs NSW/ACT. Additionally participants must also be aged over 50, are able to understand English well enough to undertake the prescribed activities and able to walk independently (those using a walking frame or long cane are eligible to participate). Participants will also include those from a range of socioeconomic and cultural backgrounds.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a marked cognitive impairment, not independently mobile and confined to wheelchairs, stationary chairs or beds.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An approved flyer will be circulated to clients of Guide Dogs NSW/ACT and a telephone number and email address will be supplied. In addition, orientation and mobility instructors from Guide Dogs NSW/ACT will provide information to their clients using the flyer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NIL
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Simple paired comparisons to compare questionnaire and short physical performance battery data; thematic analysis for qualitative data.

The sample size is 10-20 participants. This will be sufficient to investigate the acceptability and feasibility of the program through qualitative methods. The study is not powered to measure a difference in performance on the physical measures and Late Life Function and Disability instrument, but will give an indication of a likely effect size which can be assessed in a larger trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/10/2013
Actual
11/10/2013
Date of last participant enrolment
Anticipated
30/10/2013
Actual
10/11/2013
Date of last data collection
Anticipated
Actual
30/05/2014
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7409 0
2067 - Chatswood
Recruitment postcode(s) [2] 7410 0
2148 - Blacktown
Recruitment postcode(s) [3] 7411 0
2103 - Mona Vale
Recruitment postcode(s) [4] 7412 0
2042 - Newtown

Funding & Sponsors
Funding source category [1] 288080 0
Other
Name [1] 288080 0
Injury Division, The George Institute for Global Health
Country [1] 288080 0
Australia
Primary sponsor type
Other
Name
Injury Division, The George Institute for Global Health
Address
Level 13, 321 Kent Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 286804 0
None
Name [1] 286804 0
NIL
Address [1] 286804 0
Country [1] 286804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290007 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 290007 0
Research Integrity
Research Portfolio
Level 2, Margaret Telfer
The University of Sydney
NSW 2006
Ethics committee country [1] 290007 0
Australia
Date submitted for ethics approval [1] 290007 0
22/08/2012
Approval date [1] 290007 0
02/10/2013
Ethics approval number [1] 290007 0
2013/792

Summary
Brief summary
The purpose of this pilot study is to test the effectiveness of the Lifestyle-Integrated Functional Exercise Program (LiFE) in reducing the incidence of falls amongst the vision impaired population aged over 50.This population group is at particularly high-risk of falls, particularly those causing serious injury.
The LiFE program has been shown to be effective in reducing the incidence of falls in the over 50 age group, who have fallen previously, by improving the balance and strength of participants. However, vision impairment has not been a specific focus of these studies. Therefore with the success of this program this raises a potential for larger scale interventions to ultimately prevent injurious falls amongst this population.
Trial website
NIL
Trial related presentations / publications
Keay L, Saich F, Clemson L, Middlemiss L, Johnson J, Tumanik H, Taylor J, Munro J, Borkowski E, Tinsley F. Feasibility and acceptability of orientation and mobility instructors delivering the LiFE falls prevention program to older people with vision impairment. International Journal of Orientation and Mobility, 7(1):22-33, 2015
Public notes

Contacts
Principal investigator
Name 43438 0
Dr Lisa Keay
Address 43438 0
The George Institute for Global Health
Level 13, 321 Kent Street
Sydney NSW 2000
Country 43438 0
Australia
Phone 43438 0
+61296570335
Fax 43438 0
+61296570301
Email 43438 0
[email protected]
Contact person for public queries
Name 43439 0
Lisa Keay
Address 43439 0
The George Institute for Global Health
Level 13, 321 Kent Street
Sydney NSW 2000
Country 43439 0
Australia
Phone 43439 0
+61296570335
Fax 43439 0
+61296570301
Email 43439 0
[email protected]
Contact person for scientific queries
Name 43440 0
Lisa Keay
Address 43440 0
The George Institute for Global Health
Level 13, 321 Kent Street
Sydney NSW 2000
Country 43440 0
Australia
Phone 43440 0
+61296570335
Fax 43440 0
+61296570301
Email 43440 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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